Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine, cisplatin, nab-paclitaxel, durvalumab | Experimental | Participants receive nab-paclitaxel over 30 minutes, cisplatin over 60 minutes, and gemcitabine over 30 minutes on days 1 and 8; durvalumab over 60 minutes on days 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | 25mg/m2;d1, 8, 21 d cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of completion of all preoperative and operative therapy | Completion of all therapy rate will be recorded. | Up to 9 weeks after study start |
| Incidence of adverse events | Will be monitored using method of Thall, Simon and Estey, and will be tabulated by the maximum reported Common Terminology Criteria for Adverse Events (CTCAE) grade. | Up to 1 years after study start |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate defined as the percentage of patients who will have complete response (CR), partial response (PR) or stable disease (SD) after the neoadjuvant therapy | Will be evaluated according to Response Evaluation Criteria in Solid Tumor (RECIST). | Up to 9 weeks after study start |
| Rate of R0 resection |
Not provided
Inclusion Criteria:
Confirmed as malignant tumor of biliary tract by pathological diagnosis;
Computed tomography (CT) or magnetic resonance imaging (MRI) shall be performed with high-quality cross-sectional imaging, and diagnosed as resectable high-risk biliary malignant tumors, limited to the liver, bile duct and/or regional lymph nodes (at least one of the following criteria must be met) :
The patient's gender is not limited, and the age is 18-75 years old; Life expectancy>3 months;
Within one week of enrollment, the ECOG PS score was 0 or 1;
No serious complications, such as hypertension, coronary heart disease and psychiatric history, and no serious allergic history; Non pregnancy and non lactation period;
The patient's organ and blood system functions meet the requirements:
The patient can understand and sign the informed consent form to participate in the trial study; can follow up with good compliance.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huikai Li, M.D. | Contact | +8618622228639 | tjchlhk@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Cancer Hospital Airport Hospital | Recruiting | Tianjin | Tianjin Municipality | 300308 | China |
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| C000613593 | durvalumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine | Drug | 1000mg/m2;d1, 8, 21 d cycle |
|
|
| Nab-paclitaxel | Drug | 100mg/m2;d1, 8, 21 d cycle |
|
|
| Durvalumab | Drug | 1000mg;d1, 21 d cycle |
|
|
R0 resection is defined as no tumor remains at the cutting edge and no tumor cells remain at the cutting edge under the microscope |
| Up to 9 weeks after study start |
| Recurrence-free survival (RFS) | RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. If a patient did not have an event (i.e. disease recurrence or death) by the time of final analysis, patient will be censored at the last disease evaluation time. | Up to 1 years after study start |
| Overall survival (OS) | OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date. | Up to 1 years after study start |
| D006571 |
| Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |